This blog replaces the earlier archives I had posted on the Internet and includes various memos sent to the clients of the VitaminLawyer.com (now the Vitamin Consultancy). It includes archived copies of memos from 2004 through 2007 and subsequent memos will be posted as they are issued.

1. Excerpts from the FDA announcement follows. The terminology is fairly much what I had predicted in previous postings, focusing on “identity, purity, strength, and composition” – however, the enforcement procedures seem more extreme than had been predicted from the draft rule and may represent a further ratcheting of enforcement in general.

Announcement: “The U.S. Food and Drug Administration today (06/22/07) announced a final rule establishing regulations to require current good manufacturing practices (cGMP) for dietary supplements. The rule ensures that dietary supplements are produced in a quality manner, do not contain contaminants or impurities, and are accurately labeled. ***

The regulations establish the cGMP needed to ensure quality throughout the manufacturing, packaging, labeling, and storing of dietary supplements. The final rule includes requirements for establishing quality control procedures, designing and constructing manufacturing plants, and testing ingredients and the finished product. It also includes requirements for recordkeeping and handling consumer product complaints. ***

Under the final rule, manufacturers are required to evaluate the identity, purity, strength, and composition of their dietary supplements. If dietary supplements contain contaminants or do not contain the dietary ingredient they are represented to contain, FDA would consider those products to be adulterated or misbranded.

The aim of the final rule is to prevent inclusion of the wrong ingredients, too much or too little of a dietary ingredient, contamination by substances such as natural toxins, bacteria, pesticides, glass, lead and other heavy metals, as well as improper packaging and labeling. ***

FDA also is issuing an interim final rule that outlines a petition process for manufacturers to request an exemption to the cGMP requirement for 100 percent identity testing … if it can provide sufficient documentation that the reduced frequency of testing requested would still ensure the identity of the dietary ingredient. ***

The final CGMP and the interim final rule are effective August 24, 2007. To limit any disruption for dietary supplements produced by small businesses, the rule has a three-year phase-in for small businesses. Companies with … less than 500 employees have until June 2009 to comply, and companies with fewer than 20 employees have until June 2010 to comply with the regulations.

http://www.fda.gov/bbs/topics/NEWS/2007/NEW01657.html

It is certainly time to make sure your Standard Operating Procedures meet the new standards, as those standards become effective. I will continue to monitor this situation and inform this email list as modified SOP documents are ready.

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2. Health Freedom Blog Upgraded

The Vitamin Lawyer has just started a Health Freedom Blog at Blogspot.com. The address is: http://vitaminlawyerhealthfreedom.blogspot.com – the earliest postings from my original health freedom blog at http://tinyurl.com/yo5t4t have been reorganized to start the replacement Blogspot blog. Additional material is added as available.

About Me

The Vitamin Conslutancy - www.vitaminconsultancy.com -- I practiced law for 36 years in NJ (1971 - 2006), gaining a reputation as The Vitamin Lawyer, representing people in the Natural Products, Dietary Supplements and CAM (Complementary and Alternative Modalities) fields. Now I provide educational services and I consult with lawyers and other professionals, formulators, manufacturers and purveyors of natural and nutritional products, as well as with CAM enterprises and practitioners.
I started these blogs to comment on health and freedom issues and to provide an archive of information for my clients and associates. This is a private expressive association communication.
I have been a trustee of several NGOs (nongovernmental organizations) including the Natural Solutions Foundation - globalhealthfreedom.org - Institute for Health Research - inhere.org - Sound Health Research Institute - soundhealthresearch.org and LifeSpirit Church - lifespirit.org